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SYMPHONY 2020-00-410Recalls & reported problems

Medos International Sàrl · SYMPHONY OCT SYSTEM POLYAXIAL SCREW DRIVER TISSUE SLEEVE · Class 1

All models of SYMPHONY (113)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
4
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10705034533230), received between Jan 3, 2020 and Sep 9, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (4 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 2 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520262
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Device-Device Incompatibility4
  • Material Twisted/Bent2

Patient problems

  • No Clinical Signs, Symptoms or Conditions2
  • No Consequences Or Impact To Patient2

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

  • MalfunctionSep 9, 2025Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

    IT WAS REPORTED THAT TWO OF THE SCREWDRIVERS ON THE SYMPHONY SET ARE DISENGAGING FROM THE SCREWDRIVERS DUE TO THE SCREWDRIVER TIPS BEING WORN. THE INSTRUMENT DID NOT BREAK INTO TWO OR MORE PIECES. THIS CAUSED A SLIGHT DELAY IN OPERATING TIME AS WE HAD TO OPEN ANOTHER KIT BUT DID NOT HAVE ANY ADVERSE EFFECT ON THE PATIENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23007370 ↗
  • MalfunctionSep 9, 2025Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

    IT WAS REPORTED THAT TWO OF THE SCREWDRIVERS ON THE SYMPHONY SET ARE DISENGAGING FROM THE SCREWDRIVERS DUE TO THE SCREWDRIVER TIPS BEING WORN. THE INSTRUMENT DID NOT BREAK INTO TWO OR MORE PIECES. THIS CAUSED A SLIGHT DELAY IN OPERATING TIME AS WE HAD TO OPEN ANOTHER KIT BUT DID NOT HAVE ANY ADVERSE EFFECT ON THE PATIENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23007356 ↗
  • MalfunctionAug 12, 2020Device-Device Incompatibility; Device-Device Incompatibility

    IT WAS REPORTED THAT ON (B)(6) 2020, DURING AN UNKNOWN PROCEDURE THEY WERE REINSERTING A SCREW TO THE PATIENT WITH A TFNA SCREWDRIVER AND THEY COULD NOT RETRACT THE SCREWDRIVER. THE SCREWDRIVER WOULD NOT RETRACT BACK TO DISENGAGE FROM THE SCREW. THERE WERE NO PATIENT CONSEQUENCES. THERE WAS A SURGICAL DELAY OF THREE (3) MINUTES. PROCEDURE OUTCOME IS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREWS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). THIS COMPLAINT INVOLVES FOUR (4) DEVICES. THIS REPORT IS FOR (1) TISSUE SLEEVE FOR POLY DRIVER. THIS IS REPORT 3 OF 4 FOR (B)(4).

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 10396008 ↗
  • MalfunctionJan 3, 2020Device-Device Incompatibility; Device-Device Incompatibility

    THIS IS REPORT 2 OF 3 FOR (B)(4).

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9547330 ↗

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Sources and updates

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